FDA.reportPublic FDA data

Shur-Clens

Primary DI
10860006476059
Brand
Shur-Clens
Company
Asept Pak, Inc.
Model
980097
Device description
Case of 24 Containers of Sodium Hypochlorite Solution in 120 mL BFS Container
Published
2025-04-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FQHLavage, Jet

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860006476059PrimaryGS10
00860006476052Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000647605910860006476059
00860006476052008600064760528600064760520860006476052

GMDN Terms#

Term, Definition table
TermDefinition
Pressure-regulated wound irrigation solution applicator, manualA hand-held manual device in the form of a compressible bottle with a specialized nozzle, intended to be used to apply a pressure-regulated jet stream of non-medicated topical solution (e.g., sterile water, saline) to mechanically irrigate, clean/moisten, and decontaminate a wound. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
005245137
Device count
24
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850073677032Shur-Clens9801032026-02-17
00850073677056Skin-Clens9801052026-02-17
10850073677039Shur-Clens9801032026-02-17
00850073677063Skin-Clens9801052026-02-17
10850073677008Shur-Clens9800992025-04-30
20850073677005Shur-Clens9800992025-04-30
10860006476035Shur-Clens9800932025-04-23
00860006476038Shur-Clens9800932025-04-23
10850073677015Shur-Clens9801012025-04-16
10860006476028Shur-Clens9800982025-04-16
10860006476042Shur-Clens9800962025-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B674PL30010PerilavStiehl Tech, LLCFQH2026-05-13
B674T93LF10PerilavStiehl Tech, LLCFQH2026-05-13
07640407460811debritom+Medaxis AGFQH2026-04-17
07649996166302debritom+Medaxis AGFQH2026-04-17
07649996166043debritom+Medaxis AGFQH2026-04-08
04050147023826ErbeErbe Elektromedizin GmbHFQH2026-04-01
00382909101201SurgiphorCAREFUSION 2200, INCFQH2026-03-05
00075450844337Hy-Vee Saline Wound WashHY-VEE, INC.FQH2026-02-19
00850073677032Shur-ClensAsept Pak, Inc.FQH2026-02-17
00850073677056Skin-ClensAsept Pak, Inc.FQH2026-02-17
04050147022959ErbeErbe Elektromedizin GmbHFQH2025-10-01
04050147022942ErbeErbe Elektromedizin GmbHFQH2025-09-30
10850073677008Shur-ClensAsept Pak, Inc.FQH2025-04-30
10860006476035Shur-ClensAsept Pak, Inc.FQH2025-04-23
10850073677015Shur-ClensAsept Pak, Inc.FQH2025-04-16
10860006476028Shur-ClensAsept Pak, Inc.FQH2025-04-16
10842351180027Irrisept Accessory KitIRRIMAX CORPORATIONFQH2024-07-22
10842351120047Irrisept Antimicrobial Wound LavageIRRIMAX CORPORATIONFQH2024-07-16
10842351180010Irrisept Wound Solution KitIRRIMAX CORPORATIONFQH2024-07-01
03600040955086ElefantColoplast A/SFQH2024-04-05
03600040955116ElefantColoplast A/SFQH2024-04-05
03600040970614ElefantColoplast A/SFQH2024-04-05
03600040970645ElefantColoplast A/SFQH2024-04-05
03600040970676ElefantColoplast A/SFQH2024-04-05
03600040970737ElefantColoplast A/SFQH2024-04-05
03600040970768ElefantColoplast A/SFQH2024-04-05
03600040970799ElefantColoplast A/SFQH2024-04-05
00034197018470Premier Solution Saline Wound WashPremier Brands of America Inc.FQH2024-03-12
00032251985164Family Wellness Saline Wound WashFamily Dollar StoresFQH2024-03-10
00856276008468VitaleCELLERA LLCFQH2023-08-10